Table 1.
Study characteristics included in the meta-analysis of onabotulinumtoxinA for aesthetic and therapeutic indications.
| Study | Inclusion Criteria Related to Prior BoNT Treatment | Design |
|---|---|---|
| Cervical dystonia | ||
| Brin 2008 [10] | BoNT naive | OL |
| Glabellar lines | ||
| Carruthers 2002 [12] | No requirement | DBPC |
| Carruthers 2004 [13] | No requirement | OL |
| Carruthers 2003 [14] | No requirement | DBPC |
| Kawashima 2009 [15] | BoNT naive | OL |
| Primary axillary hyperhidrosis | ||
| Lowe 2007 [4,16] | No BoNT for this condition previously | DBPC |
| Glaser 2007 [4,17] | Only in past BoNT study | OL |
| Glaser 2015 [18] | BoNT naive | OL |
| Naumann 2001 [19] | No BoNT ≤4 months | DBPC |
| Naumann 2003 [20] | No requirement | OL |
| Pariser 2005 [4,21] | BoNT naive | OL |
| Migraine | ||
| Mathew 2005 [22] | BoNT naive | DBPC |
| Silberstein 2005 [23] | BoNT naive | DBPC |
| Aurora 2007 [24] | BoNT naive | DBPC |
| Adult post-stroke spasticity | ||
| Brashear 2002 [25] | BoNT naive | DBPC |
| Gordon 2004 [26] | No requirement | OL |
| Turkel 2002 [4,27] | No BoNT ≤4 months | DBPC |
| Elovic 2008 [28] | No BoNT ≤4 months | OL |
| Neurogenic detrusor overactivity | ||
| Schurch 2005 [29] | No BoNT for urologic condition; no BoNT for any indication ≤3 months | DBPC |
| Cruz 2011, Ginsberg 2012, Ginsberg 2013 [30,31,32], a | No BoNT for urologic condition; no BoNT for any indication ≤3 months |
DBPC |
| Kennelly 2017 [33], a | Only in past BoNT study | OL |
| Study 082P (data on file) | No BoNT for urologic condition; no BoNT for any indication ≤3 months |
DBPC |
| Lateral canthal lines | ||
| Carruthers 2014 [34], a | BoNT naive | DBPC |
| Moers-Carpi 2015 [35], a | BoNT naive | DBPC |
| Carruthers 2015 [36], a | Only in past BoNT study | DBPC |
| Overactive bladder b | ||
| Chapple 2013 [37], a | No BoNT for urologic condition; no BoNT for any indication ≤12 weeks |
DBPC |
| Nitti 2013 [38], a | No BoNT for urologic condition; no BoNT for any indication ≤12 weeks |
DBPC |
| Nitti 2016 [39], a | No requirement | OL |
| Ginsberg 2017 [40], a | No requirement | OL |
| Pediatric spasticity | ||
| Dimitrova 2022 [41], a | No BoNT for any indication ≤6 months | DBPC |
| Dimitrova 2021 [42], a | No requirement | DBPC |
| Pediatric neurogenic detrusor overactivity | ||
| Austin 2021 | No previous/current BoNT for any urologic condition | DBPC |
| Study 121R (data on file) | No requirement | OL |
Indications are ordered by year of onabotulinumtoxinA approval (see Figure 1 for approval years). Abbreviations—BoNT, botulinum toxin; DBPC, double-blind, placebo-controlled; DBPG, double-blind, parallel group; and OL, open label. a Studies not included in Naumann 2010 [4]. b Excludes neurogenic causes, which are instead included in neurogenic detrusor overactivity.